Interpretation and Reflection on the REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance(READUS-PV)
Drug safety evaluation should be integrated throughout the entire lifecycle of a drug,from pre-market to post-market.In recent years,the disproportionality analyses based on individual case safety reports such as the FDA adverse event reporting system(FAERS)has been widely used for detecting adverse drug reaction signals,providing research hypotheses for subsequent drug safety studies.However,existing studies often suffer from unclear or incomplete reporting and over-interpretation of research findings.In response to these issues,an international multi-disciplinary group of scholars developed and published the REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance(READUS-PV).This article provides a brief summary of the reporting standards,analyzes the core points of the guideline in conjunction with considerations for the appropriate design and implementation of related studies,aiming to offer researchers a reference for better conducting and reporting such studies in the future.
pharmacovigilancedisproportionality analysisindividual case safety reportdrug safetyreporting standards
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